(C-119) From Guidelines to Practice: Regulatory Insights on Wearable Tech in Clinical Studies

Background: The integration of wearable technology in clinical trials and observational studies has gained significant attention due to its potential to enhance data collection and patient monitoring. Common types of wearables mentioned in these include smartwatches, fitness trackers, patches, and belts. These devices monitor various health metrics such as heart rate, steps, electrocardiograms (ECGs), and sleep patterns. Regulatory bodies such as the FDA and EMA have established guidelines to ensure the quality and compliance of these technologies in clinical research.

Objectives: We aim to summarize the regulatory guidance provided by the FDA and EMA on the use of wearable technology in clinical studies, highlighting key considerations, frameworks, metrics, and types of wearables.

Methods: A comprehensive review of official regulatory documents and white papers from Worldwide Clinical Trials and Delve Health was conducted. The FDA's Digital Health Technologies (DHTs) for Drug Development and the EMA's Clinical Trials Regulation webpages were examined to extract relevant guidelines and recommendations.

Results: The FDA emphasizes the importance of ensuring the accuracy, reliability, and validity of data collected through wearable devices. Their framework includes digital endpoints validation, device classification, and a pre-certification program for software-based medical technologies. Key metrics include data integrity, patient privacy, and device validation. The EMA's framework focuses on data quality standards, GDPR compliance, and technical documentation requirements. Metrics for evaluation include data integrity, reliability, and adherence to ethical standards. Gaps in the provided guidance include unclear data sharing policies, data standard and format, data validation performance, and instructions on ability to use an endpoint which is yet to be recognized.

Conclusions: The regulatory frameworks established by the FDA and EMA provide a comprehensive foundation for the use of wearable technology in clinical trials. These guidelines ensure that the integration of wearables enhances the quality and efficiency of clinical research while maintaining patient safety and data integrity. Researchers and sponsors must adhere to these regulations to successfully implement wearable technology in their studies, ultimately advancing the field of clinical trials.